Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 085034
Company: SANDOZ
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
ALPHAZINE PHENDIMETRAZINE TARTRATE 35MG TABLET;ORAL Discontinued None No No
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
04/19/1978 ORIG-1 Approval

Label is not available on this site.

Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
10/10/1991 SUPPL-13 Labeling

Label is not available on this site.

02/20/1991 SUPPL-12 Labeling

Label is not available on this site.

10/24/1989 SUPPL-11 Labeling

Label is not available on this site.

06/13/1985 SUPPL-10 Manufacturing (CMC)

Label is not available on this site.

09/24/1982 SUPPL-7 Manufacturing (CMC)

Label is not available on this site.

08/30/1982 SUPPL-6 Manufacturing (CMC)

Label is not available on this site.

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